Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627946
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Ultrasound-guided Transversus Abdominis Plane Block Versus Local Wound Infiltration TAP_WI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasound-guided Transversus Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Analgesia After Cesarean Delivery a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP
Brief Summary:
The goal of this clinical trial is to learn if transversus abdominis plane TAP block will reduce the cumulative opioid consumption compared to local wound infiltration WI It will also learn about the pain scores compared between TAP and WI groups The main questions it aims to answer are
Has the pain score after cesarean section been less in TAP compared to WI group Has the cumulative consumption of opioids reduced in TAP as compared to WI group Researchers will compare TAP group with WI group based on postoperative pain score and opioid used
Participants will
Be given intervention either TAP or WI during the cesarean section Pain score will be recorded during the postoperative period at PACU 6 12 and 24 hours after cesarean section
The postoperative pain will be rescued with opioid and the cumulative use of opioids will be recorded
Has the pain score after cesarean section been less in TAP compared to WI group Has the cumulative consumption of opioids reduced in TAP as compared to WI group Researchers will compare TAP group with WI group based on postoperative pain score and opioid used
Participants will
Be given intervention either TAP or WI during the cesarean section Pain score will be recorded during the postoperative period at PACU 6 12 and 24 hours after cesarean section
The postoperative pain will be rescued with opioid and the cumulative use of opioids will be recorded
Detailed Description:
Study title
Ultrasound-guided Transversus abdominis plane block versus local wound infiltration for postoperative analgesia after cesarean delivery A randomized controlled trial
Study setting
Bhutan is a small landlocked country in the Himalayas sandwiched between China and India Its total population is over 07 million 20 Healthcare in Bhutan is publicly owned and solely state-funded It has a three-tiered health system with the primary health centers at the lowest level followed by district hospitals regional referral hospitals and the national referral hospital 21 Jigme Dorji Wangchuk JDW National Referral Hospital is a tertiary referral hospital and a teaching hospital located in the capital city Thimphu The Department of Anesthesiology at JDW National Referral Hospital administers anesthesia in eight operation rooms The department has nine anesthesiologists eleven nurse anesthetists seventeen anesthesia technicians and five residents The department also has pre-operative and post-anesthesia care unit PACU nurses
In the pre-operative room pregnant mothers posted for CS are received by the nurses who complete preoperative documentation and administer prophylactic antibiotics CS is performed by the resident under the supervision of a consultant or by a consultant obstetrician following a standard procedure under spinal anesthesia Usually heavy bupivacaine mg 25ml with fentanyl mg ml is administered
After the operation patients are brought to PACU where the nurses monitor vitals and transfer them to postoperative wards once patients are awake and hemodynamically stable
Study populations
Women undergoing elective cesarean section in JDW National Referral Hospital
Inclusion criteria
All elective cesarean sections performed under spinal anesthesia with an American Society of Anesthesiologists physical status classification II ASA II
Exclusion criteria
Those mothers underwent emergency cesarean section contraindication to spinal anesthesia increased intracranial pressure coagulopathy or local skin infection hypersensitivity to any of the drugs used in the study failed spinal anesthesia converted to general anesthesia pre-existing pain syndromes or with a history of recent opioid exposure significant cardiovascular renal or hepatic disease and fetal abnormalities or negative fetal outcomes were excluded from the study
Study period
The study was carried out from 1st January 2023 till 31st December 2023
Sample size
The sample size was calculated using the GPower version 3197 with the following imputations- Test family t tests Statistical test Mean differences between two independent means two groups Type of power analysis A priori computer required sample size Input parameters two-tailed test Type I error α 005 Type II error β 02 Power 1-β 08 allocation ratio N2N1 1 and with an effect size dz 06 The total sample size n obtained was 90
A drop-out rate of 10 was expected and the total sample taken for the study was 100 divided equally into two groups TAP n50 and WI n50
Study Procedure
An ethical clearance was obtained from the Research Ethical Board of Health Ministry of Health Bhutan with Ref No IRBApprovalPN2022-018 445 dated 10th November 2022
All the pregnant mothers posted for elective CS were approached in the pre-operative room by the investigators and obtained written informed consent to participate in the study Those mothers who voluntarily consented were recruited to the study after applying the inclusion criteria Those mothers were briefed and familiarised with the visual analogue scale VAS for pain scores
Randomization
After recruitment they were allocated into two groups transversus abdominis plane TAP block and local wound infiltration WI consisting of 50 participants in each group Allocation into two groups was done following a lottery system of randomization where each participant was made to pick up one from the basket containing 100 enclosed envelopes which consisted of 50 each for TAP and WI
Blinding
A single-blinded study was conducted where the study participants did not know which intervention they received
In the operating room patients were attached to anesthetic machines and monitored non-invasively for blood pressure pulse rate saturation and electrocardiogram All the patients were given intravenous crystalloid solution Ringers Lactate at a standard rate Spinal anesthesia consisting of a preservative-free hyperbaric 05 bupivacaine of 18ml - 22ml was administered intrathecally at the L3 - L4 level using a 27G spinal needle Failed spinal anesthesia and those converted to general anesthesia were excluded from the study
After attaining an upper sensory level of T6 or higher a standard CS with a Pfannenstiel incision was performed by the resident under supervision or by a consultant obstetrician After the delivery of the baby participants in both groups received oxytocin 30 units through infusion and intravenous paracetamol 15mgkg Intraoperative complications were managed following the same protocol for both groups bradycardia and hypotension were treated with inj ephedrine and nauseavomiting were managed inj metoclopramide 10mg
Intervention
In the TAP group after completion of CS the anesthesiologist performed a bilateral TAP block The dividing screen was kept in place and the skin was cleaned with a 10 betadine solution Under sterile precautions using a linear ultrasound probe placed over the mid-axillary line at the midpoint between the costal margin and the iliac crest the external oblique internal oblique and transversus abdominis muscles were identified A 20 G nerve block needle was advanced under direct ultrasound vision through the skin subcutaneous tissues external oblique and internal oblique and once the needle tip reached the space between the internal oblique and the transversus abdominis muscle a 20 ml of 025 bupivacaine was injected A well-defined hypoechoic elliptical shape formation confirmed the correct site of injection The same procedure was performed on the other side
In Group WI the local anesthetic wound infiltration was performed by the operating obstetrician Before the skin closure 20 ml of 025 bupivacaine was injected subcutaneously along the full length including both the upper and lower margins of the wound The dividing screen was kept in place so the patient could not determine which pain intervention was being offered to them
After the intervention following CS participants were taken to the PACU and monitored for vitals In the PACU pain scores were assessed using the VAS by the investigators and the postoperative complications including nausea vomiting pruritus and the additional medications required in the PACU were recorded
After they were shifted to the maternity ward trained maternity nurses who were not a part of the study and unaware of the treatment modality monitored and recorded the pain score opioid consumption and side effects at 6 12 and 24 hours according to the questionnaire that was handed in the patients file Postoperative rescue analgesia was given according to the standard institute obstetricians protocol with scheduled oral paracetamol and intramuscular diclofenac sodium injections with on demand opioids pethidinetramadolmorphine Ondansetron intravenous was offered for nausea and vomiting
Study end-points
Primary end-point was opioids consumption in the first 24hour after cesarean section
Secondary end-point was VAS pain score 0-10 and side effects like post operative nausea vomiting sedation and complications related to the procedure
Data analysis
Data were double-entered and validated using EpiData version 31 for entry and version 222183 for analysis EpiData Association Odense Denmark Data were exported and analyzed using SPSS version 23 The Kolmogorov-Smirnov test was performed to test for the normality of the study data Normally distributed continuous demographic and clinical characteristics variables were compared using student t-test Non-normally distributed two independent variables were compared using Mann-Whitney test The Chi square or Fishers exact test was used to analyze categorical variables and presented in frequencies and percentages The p-value of lt 005 is considered statistically significant in the study
Ultrasound-guided Transversus abdominis plane block versus local wound infiltration for postoperative analgesia after cesarean delivery A randomized controlled trial
Study setting
Bhutan is a small landlocked country in the Himalayas sandwiched between China and India Its total population is over 07 million 20 Healthcare in Bhutan is publicly owned and solely state-funded It has a three-tiered health system with the primary health centers at the lowest level followed by district hospitals regional referral hospitals and the national referral hospital 21 Jigme Dorji Wangchuk JDW National Referral Hospital is a tertiary referral hospital and a teaching hospital located in the capital city Thimphu The Department of Anesthesiology at JDW National Referral Hospital administers anesthesia in eight operation rooms The department has nine anesthesiologists eleven nurse anesthetists seventeen anesthesia technicians and five residents The department also has pre-operative and post-anesthesia care unit PACU nurses
In the pre-operative room pregnant mothers posted for CS are received by the nurses who complete preoperative documentation and administer prophylactic antibiotics CS is performed by the resident under the supervision of a consultant or by a consultant obstetrician following a standard procedure under spinal anesthesia Usually heavy bupivacaine mg 25ml with fentanyl mg ml is administered
After the operation patients are brought to PACU where the nurses monitor vitals and transfer them to postoperative wards once patients are awake and hemodynamically stable
Study populations
Women undergoing elective cesarean section in JDW National Referral Hospital
Inclusion criteria
All elective cesarean sections performed under spinal anesthesia with an American Society of Anesthesiologists physical status classification II ASA II
Exclusion criteria
Those mothers underwent emergency cesarean section contraindication to spinal anesthesia increased intracranial pressure coagulopathy or local skin infection hypersensitivity to any of the drugs used in the study failed spinal anesthesia converted to general anesthesia pre-existing pain syndromes or with a history of recent opioid exposure significant cardiovascular renal or hepatic disease and fetal abnormalities or negative fetal outcomes were excluded from the study
Study period
The study was carried out from 1st January 2023 till 31st December 2023
Sample size
The sample size was calculated using the GPower version 3197 with the following imputations- Test family t tests Statistical test Mean differences between two independent means two groups Type of power analysis A priori computer required sample size Input parameters two-tailed test Type I error α 005 Type II error β 02 Power 1-β 08 allocation ratio N2N1 1 and with an effect size dz 06 The total sample size n obtained was 90
A drop-out rate of 10 was expected and the total sample taken for the study was 100 divided equally into two groups TAP n50 and WI n50
Study Procedure
An ethical clearance was obtained from the Research Ethical Board of Health Ministry of Health Bhutan with Ref No IRBApprovalPN2022-018 445 dated 10th November 2022
All the pregnant mothers posted for elective CS were approached in the pre-operative room by the investigators and obtained written informed consent to participate in the study Those mothers who voluntarily consented were recruited to the study after applying the inclusion criteria Those mothers were briefed and familiarised with the visual analogue scale VAS for pain scores
Randomization
After recruitment they were allocated into two groups transversus abdominis plane TAP block and local wound infiltration WI consisting of 50 participants in each group Allocation into two groups was done following a lottery system of randomization where each participant was made to pick up one from the basket containing 100 enclosed envelopes which consisted of 50 each for TAP and WI
Blinding
A single-blinded study was conducted where the study participants did not know which intervention they received
In the operating room patients were attached to anesthetic machines and monitored non-invasively for blood pressure pulse rate saturation and electrocardiogram All the patients were given intravenous crystalloid solution Ringers Lactate at a standard rate Spinal anesthesia consisting of a preservative-free hyperbaric 05 bupivacaine of 18ml - 22ml was administered intrathecally at the L3 - L4 level using a 27G spinal needle Failed spinal anesthesia and those converted to general anesthesia were excluded from the study
After attaining an upper sensory level of T6 or higher a standard CS with a Pfannenstiel incision was performed by the resident under supervision or by a consultant obstetrician After the delivery of the baby participants in both groups received oxytocin 30 units through infusion and intravenous paracetamol 15mgkg Intraoperative complications were managed following the same protocol for both groups bradycardia and hypotension were treated with inj ephedrine and nauseavomiting were managed inj metoclopramide 10mg
Intervention
In the TAP group after completion of CS the anesthesiologist performed a bilateral TAP block The dividing screen was kept in place and the skin was cleaned with a 10 betadine solution Under sterile precautions using a linear ultrasound probe placed over the mid-axillary line at the midpoint between the costal margin and the iliac crest the external oblique internal oblique and transversus abdominis muscles were identified A 20 G nerve block needle was advanced under direct ultrasound vision through the skin subcutaneous tissues external oblique and internal oblique and once the needle tip reached the space between the internal oblique and the transversus abdominis muscle a 20 ml of 025 bupivacaine was injected A well-defined hypoechoic elliptical shape formation confirmed the correct site of injection The same procedure was performed on the other side
In Group WI the local anesthetic wound infiltration was performed by the operating obstetrician Before the skin closure 20 ml of 025 bupivacaine was injected subcutaneously along the full length including both the upper and lower margins of the wound The dividing screen was kept in place so the patient could not determine which pain intervention was being offered to them
After the intervention following CS participants were taken to the PACU and monitored for vitals In the PACU pain scores were assessed using the VAS by the investigators and the postoperative complications including nausea vomiting pruritus and the additional medications required in the PACU were recorded
After they were shifted to the maternity ward trained maternity nurses who were not a part of the study and unaware of the treatment modality monitored and recorded the pain score opioid consumption and side effects at 6 12 and 24 hours according to the questionnaire that was handed in the patients file Postoperative rescue analgesia was given according to the standard institute obstetricians protocol with scheduled oral paracetamol and intramuscular diclofenac sodium injections with on demand opioids pethidinetramadolmorphine Ondansetron intravenous was offered for nausea and vomiting
Study end-points
Primary end-point was opioids consumption in the first 24hour after cesarean section
Secondary end-point was VAS pain score 0-10 and side effects like post operative nausea vomiting sedation and complications related to the procedure
Data analysis
Data were double-entered and validated using EpiData version 31 for entry and version 222183 for analysis EpiData Association Odense Denmark Data were exported and analyzed using SPSS version 23 The Kolmogorov-Smirnov test was performed to test for the normality of the study data Normally distributed continuous demographic and clinical characteristics variables were compared using student t-test Non-normally distributed two independent variables were compared using Mann-Whitney test The Chi square or Fishers exact test was used to analyze categorical variables and presented in frequencies and percentages The p-value of lt 005 is considered statistically significant in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None