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injection of local anesthetic in the abdominal wall for post-cesarean section pain control

Surgical Transversus Abdominis Plane (TAP) Block for Post-Cesarean Section Pain Control in women

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000648628
Enrollment
100
Registered
2014-06-18
Start date
2013-01-01
Completion date
2014-02-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Cesarean section remains by far the most common surgical procedure performed for female population, and for sure post-operative pain is an issue that matters most. In fact, post-operative pain maybe one of the main reasons patients may refuse to do cesarean section. Post-operative analgesia can be provided for the patients in many forms starting from simple parenteral analgesics as NSAID’s and paracetamol up to neuraxial narcotics. Many local techniques have been developed to alleviate post-operative pain, tranversus abdominis plane block is a relatively newly technique that was introduced to control pain after abdominal surgeries. TAP block can be done either transcutaneous using anatomical landmarks or ultrasound guided, or can be done by open surgical technique as described here. Aim of the work: This study aims at testing the efficacy of injection of local anesthetic into a particular plane the abdominal wall (the transversus abdominis plane) in order to control the pain after cesarean section. Study the analgesic effect of the surgical transversus abdominis plane (TAP) block as regard the pain score in the post-operative period in patients undergoing Cesarean section. Objectives of this study: *Primary objective: assessing the pain score in the postoperative period either with or without the surgical TAP block. *Secondary objectives: assessment of: 1-Postoperative nausea and vomiting. 2-Early ambulation. 3-Required doses of opioid analgesics and their adverse effects. 4-Possible complication for the surgical TAP block, for example hypotension, arrhythmia or anterior abdominal wall hematoma. Patients and methods: The current study will include 100 women undergoing Cesarean section. The patients will be randomized in 2 groups, Group 1, who will receive surgical TAP block in addition to conventional analgesia (cases) and Group 2, who will receive conventional analgesia plus placebo (control group). The cases will receive surgical TAP block by the end of Cesarean section after closure of the uterus (bupivacaine 0.25%) in addition to the other conventional analgesics to control post-operative pain. Control group will receive placebo in the form of 20 ml of normal saline injected in the transversus abdominis plane on both sides. Comparison between the two groups will include post-operative pain scoring using visual analogue scale at 6, 12 and 24 hours, post-operative nausea and vomiting, side effects of material (pruritis, hypotension or arrhythmia), early ambulation and the required doses of opioid analgesia. Results: The pain scores at 6 hours during rest in the surgical TAP group ranged between 40-54 mm, while in the control group, the pain scores ranged between 49-57 mm, with p-value <0.001. This difference is statistically significant, though the difference in the pain scores were not high. Observing pain scores at 12 and 24 hours during rest showed no clinical or statistical difference. The post-operative pain scores during movement at 6 hours in the surgical TAP group ranged between 44-58 mm, while in the control group ranged between 53-61 mm, with P-value <0.001. Pain scores at 12 hours also showed statistical difference (p-value<0.010) with pain scores ranging between 24-33 mm and 22-27 mm in the TAP and control groups respectively. Lastly, pain scores at 24 hours showed no difference between both groups. As regard opioid consumption post-operatively, 11 women from the TAP group requested 1 dose (100 mg) of intramuscular pethidine compared to 21 women from the control group. Furthermore, six cases requested 2 doses (200 mg) of pethidine, two cases in the control group and four cases in the TAP group. Post-operative nausea and vomiting occurred in six women from the TAP group compared to nine women in the control group. No other side effects related to the injection of local anesthetic including pruritis, hypotension, arrhythmia or hematoma formation were noticed in both groups. Conclusion: Although ultrasound transcutaneous TAP block has shown promising and effective pain relief when used as a part of conventional multimodal post-operative analgesia, yet the surgical TAP block still needs further evaluation. We concluded in our study that surgical TAP block has provided slightly better post-operative pain relief in the 1st 6 hours and also decreased opioid consumption, however, this effect was not comparable to the results achieved by transcutaneous TAP block.

Interventions

Post-operatively, all patients will receive the conventional analgesic methods in the form of combination of non-steroidal inflammatory drugs and paracetamol as post-operative analgesia. Conventional analgesia will include intravenous diclofenac 75 mg every 12 hours and intravenous paracetamol 1000 mg every 8 hours. The cases will receive surgical TAP block by the end of Cesarean section after closure of the uterus (bupivacaine 0.25%) in addition to the other conventional analgesics to control p

Post-operatively, all patients will receive the conventional analgesic methods in the form of combination of non-steroidal inflammatory drugs and paracetamol as post-operative analgesia. Conventional analgesia will include intravenous diclofenac 75 mg every 12 hours and intravenous paracetamol 1000 mg every 8 hours. The cases will receive surgical TAP block by the end of Cesarean section after closure of the uterus (bupivacaine 0.25%) in addition to the other conventional analgesics to control post-operative pain. Control group will receive placebo in the form of 20 ml of normal saline injected in the transversus abdominis plane on both sides. Opioid analgesics in the form of IM pethidine 100 mg will be given to patients of the two groups when needed. Technique of the TAP block: After closure of the uterus, the rectus muscle is elevated superiorly using a retractor. Care should be taken to avoid any damage to the inferior epigastric vessels located at its lateral border. The nerves that supply the anterior abdominal wall travel through the neurofascial plane between internal oblique and transversus abdominis muscles. This plane can be easily be achieved by inserting a (18G) needle through the parietal peritoneum and with further needle advancement there is loss of resistance and the correct plane is entered. After careful aspiration, to ensure there’s no vascular injury, 20 ml 0.25% bupivacaine (50 mg bupivacaine) is introduced slowly. The plane will be expanded after the procedure

Sponsors

Ain Shmas University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Women undergoing Cesarean section under general anesthesia by the researcher.

Exclusion criteria

- Major systemic diseases, e.g. diabetes mellitus. - Chronic pain disorders. - Abuse of drugs or alcohol. - Allergies to any medication used in the study. - Patients with bleeding disorders. - Regional anesthesia including spinal and epidural anesthesia. - Patients with body mass index more than 35.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026